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Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT01860443
Recruitment Status : Terminated (Because there are enough data to present the conclusions)
First Posted : May 22, 2013
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Vania Martínez-Nahuel, University of Chile

Tracking Information
First Submitted Date  ICMJE May 18, 2013
First Posted Date  ICMJE May 22, 2013
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE June 2013
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2013)
Change from baseline in Beck Depression Inventory (BDI) [ Time Frame: Baseline and 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01860443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2013)
Change from baseline in KIDSCREEN-27 [ Time Frame: Baseline and 12 weeks ]
Health-related quality of life questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telepsychiatry to Improve the Management of Adolescent Depression in Primary Care
Official Title  ICMJE Telepsychiatry-Based Collaborative Program to Improve the Management of Adolescent Depression in Primary Care Clinics in the Araucanía Region, Chile: A Randomized Controlled Trial
Brief Summary

Background: Depression is common in adolescents and it is associated with serious consequences. In Chile, primary care team has a leading role in the management of depression in adolescents. Nevertheless, the majority of primary care professionals report not feeling adequately prepared to take on this responsibility and having difficulties referring patients to specialists. This situation is particularity complex in regions far away from the central zone. Telepsychiatry is a potential solution to an equitable access to specialized clinical expertise.

Purpose: The purpose of this study is to determine whether a telepsychiatry-based collaborative program is effective to improve the management of depression in adolescents between 13 and 19 years of age in 16 primary care clinics in the Araucanía Region, Chile.

Study design: A cluster-randomized clinical trial will be carried out with 237 adolescents. The efficacy, adherence, and acceptability of the telepsychiatry-based collaborative program will be evaluated.

Detailed Description

General aim To carry out a randomized controlled trial to compare the efficacy of telepsychiatry intervention versus usual care to treat depression in adolescents in primary care clinics in the Araucanía Region, Chile.

Specific aims

  1. To compare the level of depressive symptoms of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
  2. To compare the level of health-related quality of life (HRQoL) of adolescents suffering depression participating in a telepsychiatry program versus usual care in primary care clinics.
  3. To compare adolescents' adherence with a telepsychiatry program versus usual care in primary care clinics.
  4. To evaluate adolescents' satisfaction with a telepsychiatry program.
  5. To evaluate health staff's satisfaction with a telepsychiatry program.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Other: Telepsychiatry collaborative program

    The intervention includes:

    • Online training for the health staff
    • Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression
    • Online supervision in a web platform by specialists
    • Telephone monitoring
  • Other: Usual care
    • Online training for the health staff
    • Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression
Study Arms  ICMJE
  • Experimental: Telepsychiatry collaborative program
    • Online training on the diagnosis and management of adolescent depression for health professionals from primary care clinics participating in active branch.
    • Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL).
    • Supervision of primary care professionals through an internet site run by a team of specialists.
    • Telephone monitoring of patients by personnel trained on clinical progress, treatment adherence, and side effects (applicable for patients taking drugs).
    Intervention: Other: Telepsychiatry collaborative program
  • Active Comparator: Usual care
    • Online training on the diagnosis and management of adolescent depression for health professionals from primary care centers participating in active branch.
    • Clinical management of depression by primary care professionals, according to algorithms based on the Clinical Guidelines of the Chilean Ministry of Health (MINSAL).
    Intervention: Other: Usual care
Publications * Martínez V, Rojas G, Martínez P, Zitko P, Irarrázaval M, Luttges C, Araya R. Remote Collaborative Depression Care Program for Adolescents in Araucanía Region, Chile: Randomized Controlled Trial. J Med Internet Res. 2018 Jan 31;20(1):e38. doi: 10.2196/jmir.8021.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 31, 2015)
143
Original Estimated Enrollment  ICMJE
 (submitted: May 18, 2013)
237
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets diagnostic criteria of a depressive disorder according a structured interview (MINI-KID)

Exclusion Criteria:

  • Psychotic symptoms
  • Bipolar disorder
  • Current substance and/or alcohol dependence
  • Suicide risk that requires specialized treatment
  • Current treatment with antidepressant and/or psychotherapy
  • Low intellectual abilities
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01860443
Other Study ID Numbers  ICMJE FONIS SA12I1294
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vania Martínez-Nahuel, University of Chile
Study Sponsor  ICMJE University of Chile
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Vania Martínez-Nahuel, Dr.med. University of Chile
PRS Account University of Chile
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP